GW's Cannabis-Derived Drug Epidiolex On Track For Successful US Launch

Epidiolex has had an encouraging initial US launch, with GW Pharmaceuticals reaching out to physicians and payors.

Knowledge, attitudes and policies regarding medical cannabis and cannabis-based drugs are changing, and Epidiolex's availability paves the way for other cannabinoid-based drugs.

GW is looking to maximise the Epidiolex opportunity and multiple milestones are ahead in 2019, including potential European launches, plus Sativex's FDA approval is being pursued. However, Zogenix's repurposed drug has demonstrated impressive efficacy and is not far behind Epidiolex.

GW Pharmaceuticals' cannabis-derived drug Epidiolex (cannabidiol) has had an encouraging initial launch period in the US, with net sales for the November 1 to December 31 2018 launch period of USD4.7mn, and the company reaching out to physicians and payors. Epidiolex is the first plant-derived cannabinoid pharmaceutical approved by the FDA and first approved medicine in the US for Dravet syndrome, and its availability will transform GW's revenue generation. Company revenue for the quarter was up, although so was net loss; GW reported revenue for the quarter ended December 31 2018 of USD6.7mn compared to USD4.0mn for the quarter ended December 31 2017, and net loss for the quarter was USD71.9mn compared to USD61.8mn for the previous year quarter. The release of these results was followed by a jump in the company's share price, which rose from USD152.89 at close on February 26 to USD173.99 at close on the following day, an increase of 13.8%.

According to GW, the sales organisation has interacted with about 70% of the 5,000 target physicians including all Level 3 and 4 epilepsy centres. In addition, over 80% of all commercial lives (145mn) now have a coverage determination with 60% of these lives covered with either no Prior Authorization (PA) or PA to label; 99% of State Fee for Service Medicaid lives now have a coverage determination; and approximately 90% of Managed Medicaid lives have a coverage determination. Notably, prescription growth in January 2019 over December 2018 was approximately 150%, and approximately 900 expanded access programme and open-label extension patients are expected to migrate to commercial product by the end of Q219.

The FDA approved Epidiolex oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older. Beyond the US, GW is in the final stages of the European regulatory review of Epidiolex, with a CHMP recommendation expected in Q219 (Europe brandname: Epidyolex). In anticipation of a positive outcome, the company's European commercial preparations are in the final stages, for commercial launches in the first five countries later in 2019.

Knowledge, attitudes and policies regarding medical cannabis and cannabis-based drugs are changing. GW Pharmaceuticals was aiming for Epidiolex to be placed into Schedule IV, but the US Drug Enforcement Administration in fact placed it in the lowest restriction Schedule (Schedule V), whilst other, non-FDA-approved cannabidiol preparations remain in Schedule I. In addition, in November 2018, the UK Government moved cannabis-based products for medicinal use to Schedule 2, enabling their prescription by specialist clinicians. The availability of Epidiolex validates GW's platform and paves the way for other cannabinoid-based drugs, for which the industry has an active pipeline that will see increased investment.

GW is looking to maximise the Epidiolex opportunity, through new indications, formulation improvements, combinations and commercial geographies. However, it should be noted that Zogenix has completed its rolling submission of an NDA to the FDA and submitted an MAA to the EMA for Fintepla (ZX008, low-dose fenfluramine) for the treatment of seizures associated with Dravet syndrome. Both applications are based on data from two pivotal Phase III trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months. Zogenix is also investigating Fintepla in Lennox-Gastaut syndrome, for which a Phase III trial is ongoing. Zogenix's repurposed drug has demonstrated impressive efficacy and is not far behind Epidiolex.

GW Pharmaceuticals 2019 Milestones

Event

Expected

Epidiolex Commercial

European launches

Q219 onwards

Epidiolex R&D

EMA decision

Q219

Phase III tuberous sclerosis complex (TSC) data

Q219

Dravet 2 data presentation

Q219

Rett syndrome Phase III study start

Q219

TSC FDA sNDA submission

Q419

Epidiolex Life Cycle

Use/formulation patent grants

2019

Improved oral solution/capsule PK data

2019

Sativex

Phase III multiple sclerosis study start

Q419

Other Pipeline

CBDV autism/Rett studies start

H119

Neonatal hypoxic-ischaemia encephalopathy Phase II study start

H219

Source: GW Pharmaceuticals, Fitch Solutions

Epidiolex is not GW's first approved product, but the first approved in the US. GW commercialised the world's first plant-derived cannabinoid prescription drug, Sativex (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the US. GW believes that the most rapid path to FDA approval for Sativex is for an indication of spasticity in multiple sclerosis. In December 2018, the company held a meeting with the neurology division of the FDA and believes that it now has a good understanding of the optimal regulatory pathway for this product in the US. This centres on conducting an additional pivotal clinical trial. GW expects to commence this trial toward the end of 2019 and believes there are numerous follow-on indications to explore. Indeed, Alzheimer's Research UK is to fund a clinical trial at King's College London investigating Sativex for people living with dementia. The charity is committing nearly GBP300,000 (USD398,883) for a Phase II trial of Sativex, which is licensed in the UK for the treatment of muscle stiffness and tightness experienced by people with multiple sclerosis. The STAND (Sativex for the Treatment of AgitatioN in Dementia) trial will test whether it is feasible to treat agitation in people with Alzheimer's disease with the drug.